A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer

• ClinicalTrials.gov Identifier: NCT05945927
• Recruitment Status: Recruiting
• First Posted: July 14, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: June 29, 2023
• First Posted Date: July 14, 2023
• Last Update Posted Date: May 23, 2024
• Actual Study Start Date: September 13, 2023
• Estimated Primary Completion Date: March 31, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 13, 2023): Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 1 year from index date ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 13, 2023)

• Real-world Progression Free Survival (rwPFS) [ Time Frame: From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date) ]
• Time-to-treatment Discontinuation (TTD) [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to T-DM1 by Line of Therapy [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to T-DM1 by Dosage [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to T-DM1 by Dose Intensity [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to T-DM1 by Duration [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System [ Time Frame: Up to approximately 1 year from index date ]
• Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: Up to approximately 1 year from index date ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
• Official Title: An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer
• Brief Summary: This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
• Condition: Breast Cancer

Intervention

Drug: Trastuzumab emtansine

Trastuzumab emtansine will be administered as per local clinical practice and local labeling.

Other Name: T-DM1

Study Groups/Cohorts

Participants with HER2-positive Advanced Breast Cancer

Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.

Intervention: Drug: Trastuzumab emtansine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 13, 2023): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2025
• Estimated Primary Completion Date: March 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment
• Had prior treatment for breast cancer which must contain a taxane and trastuzumab
• Get the treatment of T-DM1 for the first time after diagnosis of breast cancer

Exclusion Criteria:

• Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling
• Has been previously treated with T-DM1 before current clinical visit
• Currently participating in any clinical trials
• Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Reference Study ID Number: ML44675 https://forpatients.roche.com/; 888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05945927
• Other Study ID Numbers: ML44675
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Same as current
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: May 2024